SAKURA STEAM STERILIZAER MODEL ASSV-AH06; SAKURA STEAM STERILIZER MODEL ASSV-AH06E; SKYTRON INTEGRITY 175— 510(k) K122774

Name: FDA 510(k) clearance K122774
Creator: U.S. Food and Drug Administration
Published: 2013-05-09

Substantially Equivalent

Sakura Seiki Co., Ltd.

FDA 510(k) clearance K122774 for SAKURA STEAM STERILIZAER MODEL ASSV-AH06; SAKURA STEAM STERILIZER MODEL ASSV-AH06E; SKYTRON INTEGRITY 175, Substantially Equivalent on 2013-05-09. Applicant: Sakura Seiki Co., Ltd.. Device class: 2.

Clearance details

Device name as filed: SAKURA STEAM STERILIZAER MODEL ASSV-AH06; SAKURA STEAM STERILIZER MODEL ASSV-AH06E; SKYTRON INTEGRITY 175; SKYTRON INTEG
Applicant: Sakura Seiki Co., Ltd.
Product code: Code FLE
Device class: Class 2
Regulation: 21 CFR 880.6880
Advisory panel: General Hospital
Date received: 2012-09-10
Decision date: 2013-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chikuma, Nagano, JP

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FLE

product code FLE

Malfunction: 444
Total: 444

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.